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开拓药业(09939.HK)计划於明年上半年提交普克鲁胺之新药申请
阿思达克 09-28 08:40
开拓药业(09939.HK)公布,公司正在中国开展多中心、随机、双盲、安慰剂对照的临床试验,评估普克鲁胺对进行阿比特龙及多西他赛治疗後或对其不耐受的转移性去势抵抗性前列腺癌(mCRPC)患者的疗效及安全性,已考虑来自独立数据监查委员会的建议,公司将继续进行III期临床试验,并计划於2021年上半年根据第二个主要终点(OS)的最终分析向国家药监局提交普克鲁胺的NDA申请。

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